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FDA draft rule

Read the Tea Leaves… FDA Will Require LDT Review

PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTT…

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Who’s For and Against FDA Draft LDT Rule?

CEO SUMMARY: One analysis determined that 43.2% of the public comments were in support of the proposed LDT rule and 55.2% were in opposition to the rule. More telling, however, is that of the 2,900 comments in support, only 56 were not form letters! In contrast, about 1,300 individual com…

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